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BulbiCAM

by Bulbitech AS Norway EUDAMED

Ref 001Model Advanced Video-Oculography (VOG), BulbiCAM

EMDN Z12120199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number709006642BulbiCAM3H Basic UDI-DIDate30 Mar 2026RegisteredStatusActive
European UnionCE/MDR Number709006642BulbiCAM3H Basic UDI-DIDate30 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDD, CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
Advanced Video-Oculography (VOG), 001, BulbiCAM
Primary DI / UDI-DI
07090066420006, D-BNOMF000040782001S9
Basic UDI-DI
709006642BulbiCAM3H, B-BNOMF000040782001S9
Direct Marketing DI
07090066420006
EMDN Code
Z12120199 Ophtalmology assessments and diagnosis instruments – other
Device Class
Class IIa
Class I
Market of Registration
Norway

Manufacturer details

EUDAMED SRN
NO-MF-000040782

Properties & raw data

Show properties, registry sources and raw records
  • Contains Latex YesEUDAMEDNoEUDAMED
Other properties (12)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (2)

  • EUDAMED eb48ab6f-f954-4c16-aaf2-6c6f16e76e05 61 fields · synced 22 Oct 2026
  • EUDAMED D-BNOMF000040782001S9|B-BNOMF000040782001S9 61 fields · synced 19 May 2026